Medicine
Pilocarpine 40 mg/mL eye drops
Pilocarpine 40 mg/mL eye drops is a generic prescription medicine for ophthalmic use, made by 4 labelers, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Protect from freezing. Store at 20°C to 25°C (68°F to 77°F), excursions…
Key facts
- Active ingredient (INN)
- Pilocarpine
- Brand
- Sold under the generic name
- Strength
- 40 mg/mL
- Dosage form
- Eye drops
- Route
- Ophthalmic
- Packs
- 1 bottle, 15 mL and 1 more
- Manufacturers
- Amneal Pharmaceuticals NYLeading PharmaSandozSomerset Therapeutics
- Origin register
- US FDA, United States
- Storage
- Protect from freezing. Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F and 86°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- N07AX01 Pilocarpine
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 30 September 2011
- Identifiers
- RxCUI 1000647, 1000862, 1000897DailyMed set ID 53fa0b7a-f982-48a7-92c4-6f098683c1ed, 1e87a81a-7084-4436-918b-a50451534307, 189762b1-608a-4240-b1b5-0db3278224bb +1NDC 61314-206, 69238-1747, 69315-316 +1Application NDA200890, ANDA214193, ANDA217052 +1
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1 bottle in 1 carton / 15 mL in 1 bottle | 69238-1747-8 | Amneal Pharmaceuticals NY | 23 September 2020 |
| 15 mL in 1 bottle, plastic | 69315-316-15 | Leading Pharma | 20 October 2026 |
| 1 bottle in 1 carton / 15 mL in 1 bottle | 61314-206-15 | Sandoz | 30 September 2011 |
| 1 bottle in 1 carton / 15 mL in 1 bottle | 70069-201-01 | Somerset Therapeutics | 25 November 2019 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 29 July 1974 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Other strengths and forms of Pilocarpine
Clinical summary
Pilocarpine is a cholinergic receptor agonist. It is available as tablets, eye drops and ophthalmic solution for oral use. MedsAcross supplies Pilocarpine for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about PilocarpineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Salagen prescribing information (Advanz Pharma) · U.S. National Library of Medicine, DailyMed
Need Pilocarpine 40 mg/mL eye drops for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.